MAUDE Adverse Event Report: COOPERSURGICAL, INC. LEEP SYSTEM 1000 ESU GEN

Model Number 52969

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/29/2021

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical , inc.Is currently investigating the reported condition.

Event Description

Interm.Cutting.When doctor was using the system the cautery would stop & start, restarted several times.(b)(4).Complaint not verified.No defects found.Has all updates.Leep system 1000 esu gen 52969.E-complaint- (b)(4).

Event Description

Interm.Cutting.When doctor was using the system the cautery would stop & start, restarted several times.Order: (b)(4).Complint not verified.No defects found.Has all updates.1216677-2021-00112, leep system 1000 esu gen 52969 e-complaint (b)(4).

Manufacturer Narrative

Investigation x-inspect returned samples.Analysis and findings complaint (b)(4).Distribution history: this complaint unit was manufactured at csi on 08/31/2009 under wo (b)(4) and shipped on 09/14/2009.Manufacturing record review: a review of the device history record could not be performed as the record could not be located at this time.However, at the time of manufacture, records from each unit are reviewed to ensure that product meet all specifications.Should the device history record be located, this complaint will be amended accordingly.Incoming inspection review: n/a.Service history record: this unit was returned 2/7/2020 requiring an updated diaphragmed.Historical complaint review: a review of the 2-year complaint history showed similar reported complaint conditions.Product receipt: the complaint unit was returned on repair log (b)(4).Visual evaluation: visual examination of the complaint unit revealed no physical damage.Functional evaluation: complaint unit was functionally evaluated and found to function properly.Root cause: the product tested to specification as the device was found to meet all visual and functional test specifications.Root cause not applicable as the complaint condition was not confirmed.Correction and/or corrective action no further corrective action is necessary, as the complaint condition was not confirmed.Preventative action activity coopersurgical will continue to monitor this complaint condition for trends.

• Brand Name: LEEP SYSTEM 1000 ESU GEN
• Type of Device: LEEP SYSTEM 1000 ESU GEN
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 11856998
• MDR Text Key: 262961447
• Report Number: 1216677-2021-00112
• Device Sequence Number: 1
• Product Code: HGI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K952483
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 52969
• Device Catalogue Number: 52969
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other